Bioabsorbable mesh for surgical implants

ABSTRACT

Described are methods, devices, and systems related to pelvic implants, including implants that include absorbable and non-absorbable materials.

PRIORITY CLAIM

The present non-provisional patent Application is a continuation of U.S.patent application Ser. No. 14/673,253, filed Mar. 30, 2015, which is acontinuation of U.S. patent application Ser. No. 13/579,491, filed onSep. 25, 2012, now U.S. Pat. No. 8,992,411, which is a U.S. nationalstage application under 35 U.S.C. 371 of International Application No.PCT/US2011/025015, which was granted an International Filing Date ofFeb. 16, 2011, which in turn claims priority under 35 USC § 119(e) fromU.S. Provisional Patent Application having Ser. No. 61/305,048, filed onFeb. 16, 2010, by Koullick et al. and titled BIOABSORBABLE MESH FORSURGICAL IMPLANTS wherein said applications are incorporated herein byreference in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to implantable surgical meshes,and more particularly, to implantable surgical meshes that contain bothabsorbable and non-absorbable fibers in a configuration such that, priorto absorption the absorbable fibers lend additional structural supportto the mesh for purposes of implantation and following absorption of theabsorbable fibers, the mesh is substantially open to promotetissue-ingrowth.

BACKGROUND

Implantable surgical meshes have been widely used for a variety ofdifferent surgical procedures such as hernia repair, pelvic floorrepair, urethral slings for treating fecal and urinary incontinence,implants for treating female vaginal prolapse, and many others.

For example, urinary incontinence is a disorder that generally affectswomen of all ages. The inability to control urination can impact asubject both physiologically and psychologically. Urinary incontinencecan interfere with a person's daily activity and impair quality of life.Stress urinary incontinence is one type of urinary incontinence. Actionsincluding straining, coughing, and heavy lifting can cause women withstress urinary incontinence to void urine involuntarily.

Various physiological conditions cause urinary incontinence in women.Stress urinary incontinence is generally caused by two conditions thatoccur independently or in combination. One condition, known as intrinsicsphincter deficiency (ISD), occurs when the urethral sphincter fails tocoapt properly. ISD may cause urine to leak out of the urethra duringstressful actions. A second condition, known as hypermobility, occurswhen the pelvic floor is weakened or damaged and causes the bladder neckand proximal urethra to rotate and descend in response to increases inintra-abdominal pressure. When intra-abdominal pressure increases due tostrain resulting from coughing, for example, urine leakage oftenresults.

One method for treating stress urinary incontinence includes placing asling to either compress the urethral sphincter or placing a sling toprovide a “back stop” to the bladder neck and proximal urethra.Providing support to the bladder neck and proximal urethra maintains theurethra in the normal anatomical position, while elevation places theurethra above the normal anatomical position.

A woven or knit mesh structure for the sling (or for implants to treatother pelvic conditions) is desirable in that it allows tissue ingrowthinto and through the mesh. However, problems exist in that an open weaveor knit construction that will promote tissue in-growth afterimplantation does not necessarily lend sufficient structural support tothe mesh to aid in the process of implantation. Further, providing aclosed-weave mesh that has sufficient structural support forimplantation does not necessarily provide sufficient porosity to promotetissue in-growth for long term stability.

Accordingly, there is a need for an improved implantable surgical meshthat reduces or alleviates the problems discussed above, that has theproper combination of mechanical rigidity and flexibility duringimplantation, and the proper combination of porosity and mechanicalproperties after implantation. According to the invention, the mesh caninclude degradable (absorbable) structure, and that structure can beselected to control the degradation rate of the absorbable material toprovide desired mechanical properties and also promote tissue ingrowththat mirrors natural body tissue.

SUMMARY

An object of the invention is to provide an implantable surgical meshwith sufficient rigidity for implantation while having sufficientopenness in the mesh (e.g., weave or knitted) pattern. To that endadding fibers, whose rate of absorption is controlled, to an otherwisenon-absorbable mesh is provided.

One embodiment includes a plurality of absorbable fibers and a pluralityof non-absorbable fibers. The absorbable fibers include anybiodegradable material, generally a polymeric material (e.g.,polyhydroxyalkanoate) wherein the degradation rate of the polymericmaterial is controlled through one or more of: the addition duringmanufacture of components to the polymeric composition, selection of thechemical composition (e.g., monomers used to prepare the polymer),molecular weight, processing conditions, and form of the composition. Avariety of knitted or woven patterns of the two (or more) fibers arealso provided.

In one embodiment a polypropylene non-absorbable fiber is knit or woventogether with a polyhydroxyalkanoate absorbable fiber. All of thenon-absorbable fibers are paired with a polyhydroxyalkanoate absorbablefiber as shown in FIG. 2. The resulting paired fibers are theninterwoven to form a bi-directional mesh structure prior to absorptionof the absorbable fibers. Here and throughout this disclosure, anyreference to a biodegradable polyhydroxyalkanoate polymer is understoodto be exemplary, and the polyhydroxyalkanoate polymer is understood tobe capable as a general matter of being substituted with another type ofbiodegradable material, e.g., biodegradable polymer, including but notlimited to any of: an alpha-hydroxy acid, poly-L-lactic acid,polyanhydride, polycaprolactone, polyglycolic acid, poly-L-lactic acid,poly-D-L-lactic acid, polydioxanone, polyhydroxyalkanoate, andpolyphosphate esters. Likewise, reference to non-biodegradablepolypropylene is understood to be exemplary, and the polypropylene isunderstood to be capable as a general matter of being substituted withanother type of non-biodegradable material, e.g., another polyolefin, apolyurethane, a polyester, or another non-biodegradable synthetic ornatural material.

In one embodiment, a polypropylene non-absorbable fiber is knit or woventogether with a polyhydroxyalkanoate absorbable fiber. The polypropylenenon-absorbable fibers are aligned in a single direction along an X-axiswhile the plurality of absorbable fibers are interwoven with thenon-absorbable filaments along the Y-axis to thereby form abi-directional mesh structure prior to absorption of the absorbablefibers as shown in FIG. 3A.

In one embodiment a polypropylene non-absorbable fiber is intermittentlywoven together with a polyhydroxyalkanoate absorbable fiber in anI-construction as shown in FIG. 4.

In one embodiment polypropylene non-absorbable fibers are knit or woventogether to form a mesh. The openings in the mesh are intermittently orcompletely filled with an absorbable (e.g., polyhydroxyalkanoate)material as shown in FIGS. 5A and 5B.

In one embodiment a polypropylene non-absorbable fiber is knit or woventogether with a (e.g., polyhydroxyalkanoate) absorbable fiber to formmesh 600. The (e.g., polypropylene) non-absorbable fibers may be alignedin a single direction along an X-axis while the plurality of absorbablefibers may be interwoven with the non-absorbable filaments along theY-axis. Alternatively, the plurality of absorbable fibers may be alignedin a single direction along the X-axis while the non-absorbable fibersare interwoven along the Y-axis. Polypropylene (or another type)non-absorbable fibers and polyhydroxyalkanoate (for example) absorbablefibers may then run along an axis that is offset by about 45 degrees ormore from the X and/or Y axes. Alternatively, the X and Y axis fibersmay be the polypropylene non-absorbable fibers while the fibers runningon the third axis may be exclusively polyhydroxyalkanoate absorbablefiber. This configuration is shown in FIG. 6.

In another embodiment, polypropylene non-absorbable fibers are knit orwoven together to form a mesh. Depending on the initial degree ofstiffness or rigidity that is required, a polyhydroxyalkanoate materialmay be used as a hot-melt glue intermittently at the intersectingportions of the polypropylene fibers as shown in FIG. 7. Alternativelythe polyhydroxyalkanoate material may be used at all intersecting points(not shown).

In another embodiment of a surgical mesh suitable for implantation thepolyhydroxyalkanoate material may be coated on the polypropylenenon-absorbable fibers to form a sheath, which functions as a cushionbetween the stiff polypropylene filaments and the tissue therebyreducing erosion problems. This construct is shown in FIG. 8.

In yet another embodiment, an apparatus (implant) for treating urinaryincontinence in a female or a male patient comprises a urethral slinghaving a central portion and first and second ends (or “end portions” or“extension portions”). The first and second end portions arerespectively coupled to and extend from the first and second ends of thecentral support portion. The central support portion is comprised of amesh knit or woven from bioabsorbable and non-absorbable fibers whilethe first and second end portions comprise non-absorbable fibers.Alternately, the end portions comprise a mesh including bioabsorbableand non-absorbable fibers while the central portion comprisesnon-absorbable fibers.

In one aspect, the invention relates to an implantable mesh thatincludes plurality of absorbable fibers and a plurality ofnon-absorbable fibers. Absorbable fibers are interwoven or knit withnon-absorbable fibers to form a mesh structure wherein the absorbablefibers degrade after implantation into a human subject.

In another aspect the invention relates to an implantable mesh thatincludes a plurality of non-absorbable fibers interwoven or knit toproduce a porous mesh, and absorbable polymer. The absorbable polymerdegrades after implantation into a human subject.

In another aspect the invention relates to a method of treating a pelviccondition by supporting tissue of a pelvic region. The method includes:providing an implantable mesh that contains a plurality of absorbablefibers and a plurality of non-absorbable fibers, wherein the pluralityof absorbable fiber are interwoven or knit with the non-absorbable fiberto form a mesh structure wherein said absorbable fibers degrade afterimplantation into a human subject; and implanting the mesh in a patientto support tissue of a pelvic region.

In yet another aspect the invention relates to a method of treating apelvic condition by supporting tissue of a pelvic region. The methodincludes: providing an implantable mesh that includes a plurality ofnon-absorbable fibers interwoven or knit to produce a porous mesh, andabsorbable polymer, wherein the absorbable polymer degrades afterimplantation into a human subject; and implanting the mesh in a patientto support tissue of a pelvic region.

These and other features and advantages and embodiments of the presentinvention will become apparent from the following more detaileddescription, when taken in conjunction with the accompanying drawingswhich illustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A and 1B illustrate pelvic anatomy.

FIG. 2 illustrates an embodiment of a mesh or implant.

FIGS. 3A and 3B illustrate embodiments of meshes or implants.

FIG. 4 illustrates an embodiment of a mesh or implant.

FIGS. 5A and 5B illustrate embodiments of meshes or implants.

FIG. 6 illustrates an embodiment of a mesh or implant.

FIG. 7 illustrates an embodiment of a mesh or implant.

FIG. 8 illustrates an embodiment of a mesh or implant.

FIG. 9 illustrates an embodiment of a mesh or implant.

FIG. 10 illustrates an embodiment of an implant.

FIGS. 11A and 11B illustrate embodiments of implants.

FIG. 12 illustrates an embodiment of an implant.

FIG. 13 illustrates an embodiment of an implant.

DETAILED DESCRIPTION

Although the present invention is primarily described in conjunctionwith pelvic floor repair procedures, it is to be understood that theinvention and the principles described herein can be incorporated intoany implantable surgical mesh used for any purpose.

Embodiments of a mesh can include strands (e.g., fibers) that compriseabsorbable fibers (fibers that can be broken down or absorbedbiologically when implanted in a human subject) or absorbable polymer.Absorbable fibers or strands include absorbable polymer, e.g., comprise,consist of, or consist essentially of, absorbable polymer. (A fiber“consists essentially of” absorbable polymer if the fiber is at least 95percent by weight absorbable polymer material, e.g., at least 98 percentby weight absorbable polymer material).

The absorbable polymer may be any of a variety known in the polymer andabsorbable materials arts. As used herein absorbable polymer orabsorbable strands or fibers of an implant may be made of one or aplurality of bioresorbable, biocompatible polymers, varieties of whichare known in the polymer and medical device arts. Certain examplesinclude polymers that degrade by hydrolysis, such as polymers ofalpha-hydroxy acid that include poly-L-lactic acid, polyanhydride,polycaprolactone, polyglycolic acid, poly-L-lactic acid, poly-D-L-lacticacid, polydioxanone, polyhydroxyalkanoate, and polyphosphate esters.Other examples include polymers that degrade by enzymatic degradation,including polyhydroxyalkanoate polymers. Furthermore, it is contemplatedthat blends or copolymers of the aforementioned biocompatible polymersmay be used. Exemplary such polymers are described, for example, in U.S.Pat. Nos. 6,368,346, 6,828,357, 6,610,742, 6,514,515, 6,746,685, andUnited States patent applications 2009/0162276, 2003/0069629, and2002/0188342, the entireties of which are incorporated herein byreference. The mesh also includes strands that comprise non-absorbablefibers (fibers that do not substantially break down or become absorbedbiologically when implanted in a human subject). The non-absorbablefibers or strands include polymer that is not absorbable, e.g., thatcomprises, consists of, or consists essentially of, non-absorbablepolymer. (A fiber “consists essentially of” non-absorbable polymer ifthe fiber is at least 95 percent by weight absorbable polymer material,e.g., at least 98 percent by weight absorbable polymer material).Examples include, e.g., polyolefins (e.g., polypropylene),polyurethanes, polyesters, and other natural or synthetic non-absorbablematerials.

Polyhydroxyalkanoate polymer compositions useful for preparing a varietyof biodegradable and/or bioabsorbable mesh devices are known by U.S.Pat. No. 7,268,205 to William et al, the entirety of which is herebyincorporated by reference. A biodegradable polymer can preferablyexhibit a relatively slow biodegradation, for example, having an in vivohalf-life of between three and six months or less. The polymerspreferably have a relatively low melting point/glass transitiontemperature, for example, less than 136° C., and/or are soluble in anon-toxic, non-halogenated solvent, for ease of processing. Animplantable surgical mesh is provided, one embodiment of which includesa plurality of absorbable fibers and a plurality of non-absorbablefibers.

The form of the mesh, including the structure of an interwoven orknitted mesh, can be any useful or known structures or anyfuture-developed structure. The structure can be formed by any know orfuture-developed methods of weaving, knitting, or forming a mesh.

One example of a mesh structure is the type of structure referred to as“warp knitted” fabric structure. Examples are identified and discussed,e.g., at U.S. Pat. No. 4,015,451, the entirety of which is incorporatedherein by reference. Another example of a mesh structure is the type ofstructure referred to as “warp knitted loop net fabric,” examples ofwhich are identified and discussed, e.g., at U.S. Pat. No. 5,771,716,the entirety of which is incorporated herein by reference. Still anotherexample of a mesh structure is the type of structure referred to as“knitted surgical mesh,” as identified and discussed, e.g., at U.S. Pat.No. 6,287,316, the entirety of which is incorporated herein byreference. See also, U.S. Pat. Nos. 6,408,656, 6,443,964, and 6,638,284,the entireties of which are incorporated herein by reference.

Referring now to FIGS. 1A and 1B, the pubocervical fascia within thepelvic cavity of a female is shown in detail. These figures illustratethe pubocervical fascia relative to the pelvic bones and especially tothe ischial spine and ischial tuberosity, as well as the pubic bone andobturator fossa rami, and also relative to the urethra 102, the bladder104, the cervix 106, and the vagina 108. The horizontal portion of thepubocervical fascia 110 supports the bladder and vagina, and extendslaterally from the tissue surrounding the vagina, outward to the fascialwhite line 112. The distal or vertical portion of the pubocervicalfascia 114 supports the urethra and urethrovesical junction and providesa backstop against which the urethra is compressed during strainingactivity, such as coughing. As shown, the horizontal pubocervical fasciaincludes multiple striations that primarily extend laterally in thedirection described above (between the fascial white line and thevaginal tissue), with very little cross-linking between thesestriations. Thus, in the natural state of the horizontal portion of thepubocervical fascia, the striations extend primarily in a singledirection. The same is true for the vertical pubocervical fascia, andfor the uterosacral ligaments 116. Those skilled in the art willappreciate that the novel meshes disclosed herein are not limited totheir use in urethral slings but rather can be incorporated into avariety of mesh products to treat pelvic health issues.

One embodiment of the present invention is illustrated in FIG. 2. Themesh 200 is a plain weave mesh including the pairing of an absorbablefiber 202 with a non-absorbable fiber 204 (referred to as a fiber pairstrand). The fibers 202, 204 are positioned (e.g., as a fiber pairstrand) next to one another and extend along the length of the mesh onthe Y-axis and along the width of the mesh on the X-axis. In the weavinglexicon, each weft yarn or weft strand (or weft fiber) is a fiber pairstrand that includes an absorbable fiber 202 and a non-absorbable fiber204; likewise in mesh 200 each warp yarn or warp strand (or warp fiber)is a fiber pair strand that includes an absorbable fiber 202 and anon-absorbable fiber 204. This construct provides the initial stiffnessrequired to manipulate the mesh prior to implantation. Followingabsorption of the absorbable fibers, an open-weave mesh (of thenon-absorbable fibers 204) remains that promotes tissue in-growth.

One embodiment of the present invention is illustrated in FIG. 3A. Themesh 300A is a plain weave formed by a (e.g., polypropylene)non-absorbable fiber 302 knit or woven together with a (e.g.,polyhydroxyalkanoate) absorbable fiber 304. The (e.g., polypropylene)non-absorbable fibers 302 are aligned in a single direction (e.g., weft)along an X-axis, while the plurality of absorbable fibers 304 areinterwoven with the non-absorbable filaments 302 along the Y-axis (e.g.,warp) to thereby form a bi-directional mesh structure prior toabsorption of the absorbable fibers. The remaining mesh will havesubstantial or relatively greater flexibility in the Y-direction, andrelatively less flexibility in the X-direction where the non-absorbablefilaments (302) remain, after absorption of the absorbable fibers (304).Those of skill in the art can appreciate that the non-absorbable fiber302 may be positioned in a single direction along the Y-axis while theplurality of absorbable fibers 304 are positioned and interwoventherewith along the X-axis. In such case, the remaining mesh will havesubstantially flexibility in the X-direction and less flexibility in theY-direction where the non-absorbable filaments remain.

An alternate embodiment of the present invention is illustrated in FIG.3B. The mesh 300B is a plain weave formed by alternating strands ofnon-absorbable fibers 302 and absorbable fibers 304 aligned in a singledirection (e.g., weft) along an X-axis, and alternating strands ofnon-absorbable fibers 302 and absorbable fibers 304 extending along theY-axis (e.g., warp), to thereby form a bi-directional mesh structureprior to absorption of the absorbable fibers.

Another embodiment, illustrated in FIG. 4, includes a mesh 400 formedfrom (e.g., polypropylene) non-absorbable fibers 402 intermittentlywoven together with (e.g., polyhydroxyalkanoate) absorbable fibers 404in an I-construction. As illustrated, the weft direction (x-axis asillustrated) includes absorbable fiber strands 404 alternating withfiber pair strands (a pairing of an absorbable fiber 404 with anon-absorbable fiber 402). The warp direction (y-axis as illustrated)includes non-absorbable fiber strands 402 alternating with fiber pairstrands (a pairing of an absorbable fiber 404 with a non-absorbablefiber 402).

Still referring to mesh 400, this mesh is an embodiment of a mesh (e.g.,woven mesh) that includes a different (e.g., greater or lesser) relativeamount (e.g., percent) of absorbable strands per non-absorbable strandsin one direction (e.g., a weft or a warp direction) relative to theamount or percent or absorbable strands, per non-absorbable strands, inthe perpendicular direction (the warp or the weft direction,respectively). The initial construction of such a mesh will have thenecessary stiffness for manipulating the implant prior to implantation.After implantation of mesh 400, and absorption of absorbable strands,the relative flexibility of mesh 400 in one direction (e.g., the Xdirection) will be reduced relative to the flexibility in the otherdirection (e.g., the Y direction)—as illustrated, upon absorption of therelatively more absorbable fibers (404) that extend in the weftdirection, a larger percentage of non-absorbable filaments (402) remainin the warp direction, resulting in greater flexibility in the weftdirection relative the warp direction.

Another embodiment, illustrated in FIGS. 5A and 5B, includes (e.g.,polypropylene) non-absorbable fibers 502 knit or woven together to forma mesh 500. The openings 504 in the mesh are intermittently orcompletely filled with a polyhydroxyalkanoate material 505 as shown inFIGS. 5A and 5B.

In another embodiment of the present invention, illustrated in FIG. 6, a(e.g., polypropylene) non-absorbable fiber 602 is knit or woven togetherwith a (e.g., polyhydroxyalkanoate) absorbable fiber 604. Absorbable andnon-absorbable fibers can be arranged (woven, knit) in any arrangementof weft and weave strands (for woven mesh) or column and row strands(for knitted mesh), either type of woven or knitted mesh additionallybeing constructed to include one or more added strand that is woven,knitted, or otherwise situated within or attached to the woven orknitted mesh. For example, (e.g., polypropylene) non-absorbable fiberscan be aligned in a single direction along of a weave an X-axis (602)while absorbable fibers are interwoven with the non-absorbable filamentsalong the Y-axis (604) to form mesh 600. Alternatively, a plurality ofabsorbable fibers may be aligned in a single direction along the X-axis(602) while non-absorbable fibers are interwoven along the Y-axis (604).Still alternately, one or both of X-axis fibers (602) and Y-axis (604)fibers may include a combination of absorbable and non-absorbablefibers. Polypropylene (for example) non-absorbable fibers andpolyhydroxyalkanoate (for example) absorbable fibers may then run in oneor more additional direction (“axis”) such as along an axis that isoffset by about 45 degrees or more from the X and/or Y axes.Alternatively, the X and Y axis fibers may be (e.g., polypropylene)non-absorbable fibers while the fibers running on the third direction(axis) may be exclusively (e.g., polyhydroxyalkanoate) absorbable fiber.Additionally, those of skill in the art will appreciate that a fourth orfifth axis can be added to this configuration depending on the degree ofinitial stiffness required of the mesh.

In another embodiment illustrated in FIG. 7, (e.g., polypropylene)non-absorbable fibers 702 are knit or woven together to form mesh 700.Absorbable (e.g., polyhydroxyalkanoate) material 704 may be placed atintersecting portions 706 of the knit or woven fibers, e.g., used as ahot-melt glue at the intersecting portions 706 of (e.g., polypropylene)fibers 702 as shown in FIG. 7. The absorbable (e.g.,polyhydroxyalkanoate) material 704 may be positioned at all ofintersecting points 706 of the mesh, randomly (as shown), or in aparticular pattern.

Yet another embodiment of a mesh (800) of the present invention isillustrated in FIG. 8. In this embodiment, the (e.g.,polyhydroxyalkanoate) absorbable material 804 may be coated on (e.g.,polypropylene) non-absorbable fibers 802 to form a coating, covering, or“sheath,” which functions as a cushion between the stiff polypropylenefilaments and the tissue to thereby reduce erosion problems.

In yet another embodiment illustrated in FIG. 9, polypropylene fibers902 are knitted together to form mesh 900. Polyhydroxyalkanoate (oranother) absorbable polymeric material 904 may be applied to the anyportion of a knit fiber 900. For example, as illustrated, absorbablematerial may be coated or otherwise located at adjacent loops (orbights) 906 of a course of a single strand of a knitted structure, toprovide directional stiffening. Alternately, a knit mesh may be made ofalternating courses of absorbable and non-absorbable fibers, or ofmostly non-absorbable fibers with regularly-intermittent absorbablefibers (e.g., every other course may be absorbable, or every third, orevery fourth, or every fifth, tenth, or twentieth, course may beabsorbable fiber). As another possible structure, absorbable materialmay be coated or otherwise located at one or more wale or at a portionof one or more wale, optionally at regularly-intermittent wales.

In yet another embodiment illustrated in FIG. 10, non-absorbable (e.g.,polypropylene) fibers 1002 are knitted or woven together to form mesh1000. Absorbable (e.g., polyhydroxyalkanoate) polymeric material 1004may be applied around the border of the mesh structure to stiffen andmaintain the desired mesh shape during implantation, initial healing,and tissue-ingrowth.

Alternatively, as illustrated in FIG. 11A anchoring arms (or “endportions” or “extension portions”) 1101 of a mesh prosthesis (implant)1100 are knit or woven entirely of (e.g., consist of or consistessentially of) absorbable (e.g., polyhydroxyalkanoate) polymeric fibers1102 to provide adequate support during healing and tissue in-growthwhile eliminating the palpable permanent banding effect across thevagina observed with current prostheses. FIG. 11B shows the arms of asling implant 1104 made entirely (or alternatively randomly woven with)absorbable (e.g., polyhydroxyalkanoate) polymeric fibers 1102. A mesh,or portion of an implant such as an end portion or a central or tissuesupport portion is considered to “consist essentially of” absorbablepolymer if the mesh or portion of implant is at least 95 percent byweight absorbable polymer material, e.g., at least 98 percent by weightabsorbable polymer material.

In another embodiment shown in FIG. 12 a segmented prosthesis 1200 isillustrated. The segmented prosthesis 1200 is constructed ofnon-absorbable (e.g., polypropylene) mesh segments 1202 joined bysections of absorbable (e.g., polyhydroxyalkanoate) material 1204. Thisadvantageously may decrease the incidence of dyspareunia by increasingvaginal elongation and flexibility while maintaining essential lateralsupport.

In yet another embodiment shown in FIG. 13 the attachment points 1302 ofthe anchoring arms 1304 of sling prosthesis 1300 may comprise attachmentpoints of absorbable (e.g., polyhydroxyalkanoate) material.

The meshes disclosed herein can be manufactured by any well knownweaving or knitting techniques. For example, weaving can use a shuttleloom, Jacquard loom or Gripper loom. In these looms the process ofweaving remains similar, the interlacing of two systems of yarns atright angles. This lacing can be simple as in a plain weave where thelacing is over one and under one. Placing the absorbable fibers in onedirection, either fill or wrap will result in a final remaining productof the non-absorbent fibers running in one direction. Alternatively, theplain weave may be configured in a more elaborate construction such astwill weave or satin weave.

Another method of weaving is a leno weave. In this construction two warpyarns are twisted and the fill yarns are passed through the twist. Inthis type of weaving the warp yarns can be polypropylene (or anothernon-absorbable material) while the fill yarn is polyhydroxyalkanoatefibers (or another absorbable material). Alternatively, for a more openconstruction the warp yarns can be polyhydroxyalkanoate while the fillyarn is polypropylene. Those skilled in the art will appreciate thatadditional variations of the basic weaves such as, sateen weaves,antique satin, warp faced twills, herringbone twills and the like can beused to create woven fabrics that will produce the same results when oneof the directional yarns absorbs.

Other types of meshes can be constructed by knitting, which is a processof making cloth with a single yarn or set of yarns moving in only onedirection. In weaving, two sets of yarns cross over and under eachother. In knitting, the single yarn is looped through itself to make thechain of stitches. One method to do this is described as weft knitting.Knitting across the width of the fabric is called weft knitting.

Whether a woven or knit mesh is chosen, the ratio of absorbable tonon-absorbable yarns (e.g., fibers or strands) can be adjusted. Thiswill provide different amounts of structural integrity of the resultingmesh. For example, and referring to FIG. 1 using pairs of non absorbablefibers and absorbable fibers would produce a final fabric, afterabsorption, with a larger open space between the non-absorbable fibers.Variations on this construction type will produce a remaining fabricthat promotes either more of less scar tissue depending on the amount offabric and distance between sections. This can be adjusted for the typeof tissue being replaced. A lighter tissue, such as a fascia forsupporting or connecting organs, can use a knitted mesh that has a widersection of absorbable and a narrower section of non-absorbable fibers.

A second method for knitting a fabric or mesh is warp knitting. In thismethod the fibers are introduced in the direction of the growth of thefabric (in the y direction). Warp knitting is a family of knittingmethods in which the yarn zigzags along the length of the fabric, i.e.,following adjacent columns (“wales”) of knitting, rather than a singlerow (“course”). In this type of knitting the fibers are loopedvertically and also to a limited extent diagonally, with the diagonalmovement connecting the rows of loops. As with the weft knit fabrics,alternate yarns (fibers or strands) can be absorbable or non-absorbable.Controlling the number and ratio of absorbable to non-absorbable fiberswill control the final material configuration and again the amount oftissue in-growth. Alternating absorbable and non-absorbable fibersproduces a final construction with a narrow space between the remainingyarns, which can be filled in with tissue. As with woven fibers andmeshes, the warp knits can be adjusted to create various amounts oftissue in-growth.

An implant can include a tissue support portion (or “support portion” or“central portion” or “central support portion”) that can be used tosupport pelvic tissue such as the bladder or urethra (which includes anylocation of the bladder, urethra, bladder neck, mid-urethra, or proximalend of the urethra), vaginal tissue (anterior, posterior, central,vault, etc.), tissue of the perineum, coccygeus, levator ani, levatorhiatus, rectum, etc., as desired. During use, the tissue support portionis typically placed in contact with and optionally attached to tissue tobe supported, such as with a suture, biological adhesive, mechanicalattachment, or any other mode of attachment. An implant can additionallyinclude one or more extension portion (otherwise known as “end” portionsor “arms”) attached to the tissue support portion. Examples of pelvicimplants are described in the following exemplary documents: U.S. Pat.No. 7,070,556; U.S. Pat. No. 7,229,453; U.S. Pat. No. 6,652,450; U.S.Pat. No. 6,612,977; U.S. Pat. No. 6,702,827; United States patentpublication numbers 2004/0039453; 2005/0245787; 2006/0195011;2006/0195010; 2006/0235262; 2006/0287571; 2006/0195007; 2006/0260618;2006/0122457; 2005/0250977; International patent application numberPCT/US2006/028828, having an International Filing Date of Jul. 25, 2006;International patent application number PCT/US2007/016760, having anInternational Filing Date of Jul. 25, 2007; International patentapplication number PCT/US2007/014120, having an International FilingDate of Jun. 15, 2007; and International patent publication WO2007/097994, the entireties of each of these disclosures beingincorporated herein by reference.

An implant may include portions or sections that are synthetic or ofbiological material (e.g., porcine, cadaveric, etc.). Extension portionsmay be, e.g., a mesh as described herein. The tissue support portion maybe synthetic (e.g., as described herein) or biologic. Examples ofimplant products that may be similar to those useful according to thepresent description, optionally modified to include a mesh as describedherein, include those sold commercially by American Medical Systems,Inc., of Minnetonka Minn., under the trade names Apogee® and Perigee®for use in treating pelvic prolapse (including vaginal vault prolapse,cystocele, enterocele, etc.), and Sparc®, Bioarc®, Monarc®, andAdVance™, for treating urinary incontinence.

Exemplary implants can include a tissue support portion for placing incontact with tissue to be supported and one or more “extension” portion,the tissue support portion being useful to support a specific type ofpelvic tissue such as the urethra, bladder (including the bladder neck),vaginal tissue (anterior, posterior, apical, etc.), perineum, rectum,levator ani, coccygeus, tissue of the pelvic floor, or other tissue ofthe pelvic region. The tissue support portion can be sized and shaped tocontact the desired tissue when installed, e.g., as a “sling” or“hammock,” to contact and support pelvic tissue. A tissue supportportion that is located between two or more extension portions issometimes referred to herein as a “central support portion” or a“support portion.”

Extension portions are elongate pieces of material that extend from thetissue support portion and either are or can be connected to the tissuesupport portion, and are useful to connect to or through tissue of thepelvic region to thereby provide support for the tissue support portionand the supported tissue. One or multiple (e.g., one, two, or four)extension portions can extend from the tissue support portion aselongate “ends,” “arms,” or “extensions,” useful to attach to tissue inthe pelvic region.

An example of a particular type of pelvic implant is the type thatincludes supportive portions including or consisting of a centralsupport portion and either two, four, or six elongate extension portionsextending from the central support portion. An implant that has exactlytwo extension portions can be of the type useful for treating, e.g.,urinary incontinence (e.g., male or female stress or urge urinaryincontinence), anterior vaginal prolapse, or posterior vaginal prolapse.An implant having four or six extension portions can be useful fortreating anterior vaginal prolapse, or combinations of conditions. Theterm “supportive portions” refers to extension portions and tissuesupport portions and does not include optional or appurtenant featuresof an implant or implant system such as a sheath, connector, or thelike.

Examples of implants for treating incontinence, e.g., urethral slings,can include a central support portion and two extension portions, andmay take the form of an integral mesh strip. An exemplary urethral slingcan be an integral mesh strip with supportive portions consisting of orconsisting essentially of a central support portion and two extensionportions. Examples of urethral slings for treating male urinaryincontinence can have a widened central support portion, as discussed,for example, in Assignee's copending United States patent publicationnumbers 2006/0287571 and 2006/0235262. Other exemplary urethral slingimplants are described in Assignee's U.S. Pat. No. 7,070,556; UnitedStates publication numbers 2006/0195010 and 2006/0195007; andInternational application numbers WO 2007/097994 and WO 2007/014120; theentireties of these being incorporated herein by reference.

Examples of implants for treating vaginal prolapse can comprise acentral support portion and from two to four to six extension portions,and may take the form of an integral piece of mesh or multiple pieces ofmesh attached in a modular fashion. See, e.g., Assignee's copendingUnited States patent publication numbers 2006/0260618; 2005/0245787;2006/0122457; 2005/0250977; and International patent application numberPCT/2006/028828; the entireties of these being incorporated herein byreference.

Examples of implants for treating conditions of the pelvic floor, suchas to support tissue of the perineal body, to treat levator avulsion, totreat levator ballooning, to support or repair levator ani muscle, totighten or reduce the size of levator hiatus, to treat vaginal prolapse,or to treat fecal incontinence, may take the form of an integral pieceof mesh or multiple pieces of mesh attached in a modular fashion. See,e.g., International patent application number PCT/US2007/016760, filedJul. 25, 2007, by Kimberly Anderson, entitled SURGICAL ARTICLES ANDMETHODS FOR TREATING PELVIC CONDITIONS; the entireties of which areincorporated herein by reference.

A length of an extension portion can optionally be fixed (i.e., theextension portion does not include any form of length-adjustingmechanism). Alternate implants may include adjustment or tensioningmechanisms that allow a physician to alter the length of an extensionportion before, during, or after implantation. See, e.g., Internationalapplication number PCT/US2007/014120, filed Jun. 15, 2007, by Dockendorfet al., titled SURGICAL IMPLANTS, TOOLS, AND METHODS FOR TREATING PELVICCONDITIONS, the entirety of which is incorporated herein by reference.

According to specific embodiments of implants, various additionalcomponents and features can be incorporated for added utility orconvenience, such as components and features that facilitate surgicalimplantation. For instance, a tensioning member (e.g., suture) may beattached to an implant along a portion or entire length of an extensionportion for use in adding tension or in positioning an implant or aportion (e.g., extension portion) of an implant. A tensioning suture maybe attached at one or multiple attachment points along a length of anend portion. Multiple sutures may be used, such as two or more suturesalong a length of one extension portion, for added tensioning effect.Alternately or in addition, extension portions of an implant can includereinforcement or multiple layers. See, e.g., Assignee's copending U.S.patent application Ser. No. 11/347,063, and U.S. Ser. No. 11/347,596,the entireties of which are incorporated herein by reference. Otherembodiments of the invention do not require and can specifically excludea tensioning member such as a suture, multiple layers for end portions,and edge extension reinforcement for end portions.

Yet another optional component of an implant can be a sheath such as aflexible, plastic, transparent elongate tube (or “envelope” or “sleeve”)that can cover a portion or entire length of an extension portion. Asheath can reduce friction between the implant material and tissue of atissue path, to facilitate introduction of the implant material totissue. A sheath may also facilitate installation by allowing a surgeonto apply tension or pressure on the sheath, optionally to indirectlypressure or tension the extension portion or tissue support portion.

A method as described herein may be any method of treating a pelviccondition in a male or female patient. The method may support tissue ofa pelvic region such as a bladder, urethra, vagina, rectum, sphincter,levator tissue, etc., for treatment of urinary incontinence in a male orfemale; prolapse (e.g., any form of vaginal prolapse such as enterocele,cystocele, rectocele, vaginal vault prolapse, etc.; fecal incontinence;a torn, weakened, or damaged levator muscle (meaning any portion of thelevator muscle); levator avulsion, levator ballooning, treatment tosupport a perineal body; a method of perineal body repair; a method oftreating the levator hiatus by tightening or reducing the size of thelevator hiatus; and combinations of one or more of these.

An implant can be placed to contact pelvic tissue as desired, to supportthe tissue, and can optionally be secured to the tissue to be supported,e.g., by suturing. The implant (e.g., a portion thereof such as anelongate “extension portion” or “end portion”) or can additionally besecured to tissue of the pelvic region for additional support, such asto tissue such as: sacrotuberous ligament; sacrospinous ligament;anococcygeal ligament (“anococcygeal body ligament”); periostium of thepubic bone (e.g., in a region of the ischial tuberosity); pubourethralligament; ischial spine (e.g., at a region of the ischial spine);ischial tuberosity; arcus tendineus (used synonymously herein with theterm “white line”), e.g., through a tissue path between levator animuscle and obturator internus muscle and attached at the arcustendineus; obturator internus muscle. Alternately, an extension portionof an implant can be extended through a tissue path that leads to anexternal incision such as: by passing through tissue of the obturatorforamen to pass through an external incision at the inner thigh; passingabove the pubic bone to exit at a suprapubic incision; passing in aposterior direction to an external perirectal or perianal incision,e.g., past the coccyx bone. As another alternative, an implant orextension portion of an implant can be attached to bone or fasciathereof, such as the sacrum or pubic bone, or fascia thereof. Otherexamples of implants that can be modified according to the presentdescription to include a combination of absorbable and non-absorbablematerials, as well as methods for treating pelvic conditions, aredescribed in Applicant's copending United States patent publications2006/0287571, 2010/0256442, 2010/0261952, 2010/0263674, 2010/0261955,and 2010/0274074.

Although specific embodiments of the invention have been describedherein, it is to be understood that any weave or knit patterns, ornon-woven patterns, in which the absorbable filaments dissolve or areabsorbed is within the scope of the invention. The resultant meshes willinitially provide structural support for implantation purposes and thenwhen the absorbable fibers are absorbed, leave an open configuration fortissue in-growth.

Although several embodiments of a mesh for pelvic floor prolapse repairhave been described, those skilled in the art will recognize thatvarious other mesh configurations can also be used in conjunction withthe procedures and techniques described herein. It will be furtherapparent from the foregoing that other modifications of the inventionsdescribed herein can be made without departing from the spirit and scopeof the invention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

We claim:
 1. An implantable mesh for the treatment of a pelvic conditioncomprising: a central support portion including a plurality of weftstrands extending in a weft direction, and a plurality of warp strandsextending in a warp direction, the plurality of weft strands includingnon-absorbable polymer fibers, the plurality of warp strands includingabsorbable polymer fibers, the central support portion including aplurality of strands disposed at a non-perpendicular angle with theplurality of weft stands, the plurality of strands disposed at anon-parallel angle with the plurality of weft strands; and an extensionportion that extends from the central support portion, the extensionportion including absorbable polymer fibers.
 2. The implantable mesh ofclaim 1, wherein the absorbable polymer fibers includepolyhydroxyalkanoate.
 3. The implantable mesh of claim 1, wherein theextension portion is a first extension portion, the implantable meshincluding a second extension portion, the implantable mesh configuredfor the treatment of urinary incontinence with the central supportportion configured to support a urethra.
 4. The implantable mesh ofclaim 1, wherein the implantable mesh is configured for the treatment ofmale urinary incontinence with the central support portion configured tosupport a male urethra.
 5. The implantable mesh of claim 1, wherein thenon-absorbable polymer fibers include fibers include polypropylene. 6.The implantable mesh of claim 1, wherein the absorbable polymer fibersinclude fiber includes a polymer selected from the group consisting ofpolyhydroxyalkanoate, poly-L-lactic acid, polyanhydride,polycaprolactone, polyglycolic acid, poly-L-lactic acid, poly-D-L-lacticacid, polydioxanone, and polyphosphate ester.
 7. The implantable mesh ofclaim 1, wherein the extension portion includes non-absorbable polymerfibers.
 8. A method of treating a pelvic condition by supporting tissueof a pelvic region, the method comprising implanting the implantablemesh of claim 1 in a patient to support tissue of a pelvic region totreat the pelvic condition.
 9. The method of claim 8, wherein theextension portion is: secured to a tissue of the pelvic region selectedfrom the group consisting of sacrotuberous ligament, sacrospinousligament, anococcygeal ligament, periostium of the pubic bone, fascia ofthe sacrum or pubic bone, pubourethral ligament, ischial spine, ischialtuberosity, arcus tendineus; extended through a tissue path betweenlevator ani muscle and obturator internus muscle and attached at thearcus tendineus or obturator internus muscle; extended through tissue ofthe obturator foramen to pass through an external incision at the innerthigh; or passed above the pubic bone to exit at a suprapubic incision.